Therapeutic Omegas for Triglyceride Suppression (TOTS)

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Pregnancy

Treatments: Dietary Supplement: Intervention Omega 3 Supplementation; Dietary Supplement: Control Safflower Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04349475

20-0707

Details and patient eligibility

About

This study plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. It is normal for triglyceride levels to go up during pregnancy however some women have levels that are ~30-40% higher than normal when they reach their third trimester of pregnancy. Having high triglycerides in pregnancy may be related to an increased chance of having a baby that is large for their age. The goal of this study is to determine if taking an omega-3 fatty acid supplement can slow the rise in triglyceride levels later in pregnancy.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women between the ages of 21-39 yrs
• Pre-pregnancy BMI 28-39
• Fasting Triglyceride ≥120 mg/dL measured by 15 wks

Exclusion criteria

• Pre-gestational diabetes or prediabetes
• History of gestational diabetes,
• History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension <34wks
• Tobacco or illicit substance use
• Chronic steroid use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Omega 3 Supplementation

Experimental group

Description:

Supplementation of 4g of DHA/EPA daily

Treatment:

Dietary Supplement: Intervention Omega 3 Supplementation

Safflower Oil Supplement

Placebo Comparator group

Description:

Supplementation of Safflower Oil daily

Treatment:

Dietary Supplement: Control Safflower Oil